Back to resultsEvaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Primary Purpose
Colorectal Disorders, Surgery--Complications, Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Colorectal Bundle
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Disorders
Eligibility Criteria
Inclusion Criteria:
- aged ≥ 18 years
- Patients undergoing any left sided emergency or elective colorectal resections
- Patients should have given or will give a general consent
Exclusion Criteria:
- no general consent given
- unable to provide informed general consent
- vulnerable patients (Age < 18 years or patients with severe dementia)
- the intervention is a reoperation within 30 days of primary operation
Exclusion criteria for an antibiotic decontamination subgroup:
- known allergy to one of the applied antibiotic regimes
- active bacterial infection requiring systemic antibiotics
- IV or oral antibiotics in past 7 days prior to the planned decontamination
- terminal kidney disease
- unable to take antibiotic decontamination medication
- pregnancy or breastfeeding
- emergency or expedited surgery
Sites / Locations
- Lantonsspital AarauRecruiting
- Clarunis-universitäres BauchzentrumRecruiting
- Kantonsspital BasellandRecruiting
- Spitalzentrum BielRecruiting
- Kantonsspital LuzernRecruiting
- Kantonsspital OltenRecruiting
- Spital LimmattalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Arm
Colorectal Bundle Arm
Arm Description
Patients are treated according to current local standards
Patients are treated according to the colorectal bundle
Outcomes
Primary Outcome Measures
Comprehensive complication index
The primary endpoint is the comprehensive complication index (CCI) at 30 days after the index procedure, a continuous scale to measure surgical morbidity that has been developed on the basis of the Clavien Dindo Classification for surgical complications and summarizes and weighs all postoperative complications to a scale from 0 (no complications) to 100 (death of the patient) .
Secondary Outcome Measures
Surgical side infections
Rate of surgical side infections within 30 days
Number of patients who died within 30 days
Postoperative mortality within 30 days
Hospital length of stay
Length of hospital stay in days
Contribution margin
Measured as the difference between allocated costs and billed and payed income for a particular case
Rate of anastomotic leakage
Any radiologically or clinically diagnosed anastomotic leakage
Full Information
NCT ID
NCT04550156
First Posted
August 19, 2020
Last Updated
November 18, 2022
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Hospital Centre Biel/Bienne, Luzerner Kantonsspital, Kantonsspital Aarau, Kantonsspital Liestal, Spital Limmattal Schlieren, Kantonsspital Olten, Clarunis - Universitäres Bauchzentrum Basel
1. Study Identification
Unique Protocol Identification Number
NCT04550156
Brief Title
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Official Title
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Hospital Centre Biel/Bienne, Luzerner Kantonsspital, Kantonsspital Aarau, Kantonsspital Liestal, Spital Limmattal Schlieren, Kantonsspital Olten, Clarunis - Universitäres Bauchzentrum Basel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. The colorectal bundle is a catalog of measures consisting of several items These are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. The primary endpoint will be the complication rate measured as the comprehensive clinical index (CCI) within 30 days. Investigators will include patients that undergo elective or emergency left sided colorectal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Disorders, Surgery--Complications, Colorectal Cancer, Anastomotic Leak, Complication of Surgical Procedure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised, multicenter trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Patients are treated according to current local standards
Arm Title
Colorectal Bundle Arm
Arm Type
Experimental
Arm Description
Patients are treated according to the colorectal bundle
Intervention Type
Procedure
Intervention Name(s)
Colorectal Bundle
Intervention Description
Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support
Preoperative showering with an antiseptic agent
Administer preoperative antibiotic prophylaxis
Hair removal in the operative field with clippers
Peri-, intra-, and postoperative warming to maintain body temperature
Peri- and intraoperative glucose control
Usage of a wound protection device
Change of gloves and instruments after anastomosis
Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures
Primary Outcome Measure Information:
Title
Comprehensive complication index
Description
The primary endpoint is the comprehensive complication index (CCI) at 30 days after the index procedure, a continuous scale to measure surgical morbidity that has been developed on the basis of the Clavien Dindo Classification for surgical complications and summarizes and weighs all postoperative complications to a scale from 0 (no complications) to 100 (death of the patient) .
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Surgical side infections
Description
Rate of surgical side infections within 30 days
Time Frame
30 days
Title
Number of patients who died within 30 days
Description
Postoperative mortality within 30 days
Time Frame
30 days
Title
Hospital length of stay
Description
Length of hospital stay in days
Time Frame
immediately after discharge
Title
Contribution margin
Description
Measured as the difference between allocated costs and billed and payed income for a particular case
Time Frame
immediately after discharge
Title
Rate of anastomotic leakage
Description
Any radiologically or clinically diagnosed anastomotic leakage
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged ≥ 18 years
Patients undergoing any left sided emergency or elective colorectal resections
Patients should have given or will give a general consent
Exclusion Criteria:
no general consent given
unable to provide informed general consent
vulnerable patients (Age < 18 years or patients with severe dementia)
the intervention is a reoperation within 30 days of primary operation
Exclusion criteria for an antibiotic decontamination subgroup:
known allergy to one of the applied antibiotic regimes
active bacterial infection requiring systemic antibiotics
IV or oral antibiotics in past 7 days prior to the planned decontamination
terminal kidney disease
unable to take antibiotic decontamination medication
pregnancy or breastfeeding
emergency or expedited surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco von Strauss und Tourney, PD Dr.
Phone
+41 61 777 73 21
Email
marco.vonstrauss@clarunis.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Zuber, Prof. Dr.
Phone
+41 61 777 73 28
Email
markus.zuber@clarunis.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco von Strauss und Tourney, PD Dr.
Organizational Affiliation
Clarunis - Universitäres Bauchzentrum Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Zuber, Prof. Dr.
Organizational Affiliation
Clarunis - Universitäres Bauchzentrum Basel
Official's Role
Study Director
Facility Information:
Facility Name
Lantonsspital Aarau
City
Aarau
State/Province
Kanton Aargau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hartel, Prof. Dr.
Phone
+41 62 838 45 02
Email
mark.hartel@ksa.ch
Facility Name
Clarunis-universitäres Bauchzentrum
City
Basel
State/Province
Kanton Basel Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco von Strauss und Torney, PD Dr.
Phone
+41 61 777 73 21
Email
marco.vonstrauss@clarunis.ch
First Name & Middle Initial & Last Name & Degree
Markus Zuber, Prof. Dr.
Phone
+41 61 777 73 28
Email
markus.zuber@clarunis.ch
Facility Name
Kantonsspital Baselland
City
Liestal
State/Province
Kanton Basel-Land
ZIP/Postal Code
4410
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Rosenberg, Prof. Dr.
Phone
+41 61 925 21 51
Email
robert.rosenberg@ksbl.ch
Facility Name
Spitalzentrum Biel
City
Biel
State/Province
Kanton Bern
ZIP/Postal Code
2501
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten Viehl, Prof. Dr.
Phone
+41 32 324 37 64
Email
carsten.viehl@unibas.ch
Facility Name
Kantonsspital Luzern
City
Luzern
State/Province
Kanton Luzern
ZIP/Postal Code
6004
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürg Metzger, Prof. Dr.
Phone
+41 41 205 48 60
Email
juerg.metzger@luks.ch
Facility Name
Kantonsspital Olten
City
OLten
State/Province
Kanton Solothurn
ZIP/Postal Code
4600
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas Eisner, Dr.
Phone
+41 62 311 41 74
Email
lukas.eisner@spital.so.ch
Facility Name
Spital Limmattal
City
Schlieren
State/Province
Kanton Zürich
ZIP/Postal Code
8652
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urs Zingg, Prof. Dr.
Phone
+41 44 736 81 29
Email
urs.zingg@spital-limmattal.ch
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Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
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